HRP20200260T1 - Compositions, methods & systems for respiratory delivery of two or more active agents - Google Patents

Compositions, methods & systems for respiratory delivery of two or more active agents Download PDF

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Publication number
HRP20200260T1
HRP20200260T1 HRP20200260TT HRP20200260T HRP20200260T1 HR P20200260 T1 HRP20200260 T1 HR P20200260T1 HR P20200260T T HRP20200260T T HR P20200260TT HR P20200260 T HRP20200260 T HR P20200260T HR P20200260 T1 HRP20200260 T1 HR P20200260T1
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Croatia
Prior art keywords
particles
active agent
pharmaceutical preparation
type
preparation according
Prior art date
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HRP20200260TT
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Croatian (hr)
Inventor
Reinhard Vehring
Michael Steven Hartman
Adrian Edward Smith
Vidya B. Joshi
Sarvajna Kumar Dwivedi
David Lechuga-Ballesteros
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Pearl Therapeutics, Inc.
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First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=42269864&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=HRP20200260(T1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Pearl Therapeutics, Inc. filed Critical Pearl Therapeutics, Inc.
Publication of HRP20200260T1 publication Critical patent/HRP20200260T1/en

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    • A61K31/135—Amines having aromatic rings, e.g. ketamine, nortriptyline
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    • A61K31/135—Amines having aromatic rings, e.g. ketamine, nortriptyline
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    • A61K31/167—Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide having the nitrogen of a carboxamide group directly attached to the aromatic ring, e.g. lidocaine, paracetamol
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    • A61K31/192—Carboxylic acids, e.g. valproic acid having aromatic groups, e.g. sulindac, 2-aryl-propionic acids, ethacrynic acid 
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Claims (25)

1. Farmaceutski pripravak koji se može isporučiti iz inhalatora s odmjerenom dozom, koji sadrži: medij za suspenziju koji sadrži farmaceutski prihvatljiv propelant; najmanje tri različite vrste čestica aktivnog sredstva, pri čemu svaka od najmanje tri različite vrste čestica aktivnog sredstva sadrži različito aktivno sredstvo, pri čemu prva vrsta čestica aktivnog sredstva sadrži glikopirolat uključujući sve njegove farmaceutski prihvatljive soli, estere ili solvate, druga vrsta čestica aktivnog sredstva sadrži formoterol uključujući sve njegove farmaceutski prihvatljive soli, estere ili solvate, i treća vrsta čestica aktivnog sredstva sadrži beklometazon, budezonid, ciklezonid, flunizolid, flutikazon, metil-prednizolon, mometazon, prednizon i triamcinolon, uključujući sve njihove farmaceutski prihvatljive soli, estere ili solvate i najmanje 50% volumena čestica materijala aktivnog sredstva ima optički promjer od 4 µm ili manje; i jednu ili više vrsta čestica suspendiranih čestica koje se mogu udisati; pri čemu najmanje jedna vrsta suspendiranih čestica koje se mogu udisati sadrži perforirane fosfolipidne mikrostrukture; pri čemu ukupna masa najmanje jedne vrste suspendiranih čestica premašuje ukupnu masu najmanje jedne vrste čestica aktivnog sredstva, i tri ili više različite vrste čestica aktivnog sredstva zajednički su smještene sa suspendiranim česticama koje se udišu unutar medija za suspenziju tako da nastane ko-suspenzija.1. A pharmaceutical composition that can be delivered from a metered dose inhaler, containing: a suspension medium containing a pharmaceutically acceptable propellant; at least three different types of particles of the active agent, wherein each of the at least three different types of particles of the active agent contains a different active agent, wherein the first type of particles of the active agent contains glycopyrrolate including all its pharmaceutically acceptable salts, esters or solvates, the second type of particles of the active agent contains formoterol including all its pharmaceutically acceptable salts, esters or solvates, and the third type of active agent particles contains beclomethasone, budesonide, ciclesonide, flunizolid, fluticasone, methylprednisolone, mometasone, prednisone and triamcinolone, including all pharmaceutically acceptable salts, esters or solvates thereof and at least 50% by volume of the active agent material particles have an optical diameter of 4 µm or less; and one or more types of respirable suspended particulate matter; wherein at least one type of inhalable suspended particles comprises perforated phospholipid microstructures; wherein the total mass of at least one type of suspended particles exceeds the total mass of at least one type of active agent particles, and three or more different types of active agent particles are co-located with the suspended particles that are inhaled within the suspension medium to form a co-suspension. 2. Farmaceutski pripravak prema patentnom zahtjevu 1, naznačen time što treća vrsta čestica aktivnog sredstva sadrži aktivno sredstvo odabrano od flutikazona i budezonida.2. Pharmaceutical preparation according to claim 1, characterized in that the third type of active agent particles contains an active agent selected from fluticasone and budesonide. 3. Farmaceutski pripravak prema patentnom zahtjevu 1 naznačen time što suspendirane čestice za udisanje uključuju kalcijev klorid.3. Pharmaceutical preparation according to claim 1, characterized in that the suspended particles for inhalation include calcium chloride. 4. Farmaceutski pripravak prema patentnom zahtjevu 1 naznačen time što je fosfolipid disteroilfosfatidilkolin (DSPC).4. Pharmaceutical preparation according to patent claim 1 characterized in that the phospholipid is disteroylphosphatidylcholine (DSPC). 5. Farmaceutski pripravak prema patentnom zahtjevu 1, naznačen time što se perforirane mikrostrukture pripremaju postupkom sušenja raspršivanjem.5. Pharmaceutical preparation according to patent claim 1, characterized in that the perforated microstructures are prepared by spray drying. 6. Farmaceutski pripravak prema patentnom zahtjevu 5, naznačen time što perforirane mikrostrukture sadrže raspršivanjem osušenu emulziju perfluorooktil bromida, DSPC i kalcijevog klorida u vodi.6. Pharmaceutical preparation according to patent claim 5, characterized in that the perforated microstructures contain a spray-dried emulsion of perfluorooctyl bromide, DSPC and calcium chloride in water. 7. Farmaceutski pripravak prema patentnom zahtjevu 1, naznačen time što su suspendirane čestice uključene u medij za suspenziju u koncentraciji od sve do 30mg/mL.7. Pharmaceutical preparation according to patent claim 1, characterized in that the suspended particles are included in the medium for suspension in a concentration of up to 30 mg/mL. 8. Farmaceutski pripravak prema patentnom zahtjevu 7, naznačen time što su suspendirane čestice uključene u medij za suspenziju u koncentraciji odabranoj od između 1 mg/ml i 15 mg/ml, između 3 mg/ml i 10 mg/ml, između 5 mg/ml i 8 mg/ml, i oko 6 mg/ml.8. Pharmaceutical preparation according to claim 7, characterized in that the suspended particles are included in the suspension medium in a concentration selected from between 1 mg/ml and 15 mg/ml, between 3 mg/ml and 10 mg/ml, between 5 mg/ ml and 8 mg/ml, and about 6 mg/ml. 9. Farmaceutski pripravak prema patentnom zahtjevu 1, naznačen time što svaka najmanje jedna vrsta suspendiranih čestica ima MMAD odabran od između 10 µm i 500 nm, između 5 µm i 750 nm, i između 1 µm i 3 µm.9. Pharmaceutical preparation according to claim 1, characterized in that each at least one type of suspended particles has an MMAD selected from between 10 µm and 500 nm, between 5 µm and 750 nm, and between 1 µm and 3 µm. 10. Farmaceutski pripravak prema patentnom zahtjevu 1, naznačen time što svaka najmanje jedna vrsta suspendiranih čestica ima prosječni volumenski optički promjer odabran od između 0.2 µm i 50 µm, između 0.5 µm i 15 µm, između 1.5 µm i 10 µm, i između 2 µm i 5 µm.10. Pharmaceutical preparation according to patent claim 1, characterized in that each at least one type of suspended particles has an average volume optical diameter selected from between 0.2 µm and 50 µm, between 0.5 µm and 15 µm, between 1.5 µm and 10 µm, and between 2 µm and 5 µm. 11. Farmaceutski pripravak prema patentnom zahtjevu 1, naznačen time što propelant sadrži propelant koji je odabran od HFA propelanta, PFC propelanta i njihovih kombinacija, te pri čemu je propelant uglavnom bez dodatnih sastojaka.11. Pharmaceutical preparation according to patent claim 1, characterized in that the propellant contains a propellant selected from HFA propellant, PFC propellant and their combinations, and wherein the propellant is mostly without additional ingredients. 12. Farmaceutski pripravak prema patentnom zahtjevu 1, naznačen time što je omjer ukupne mase najmanje jedne vrste suspendiranih čestica prema ukupnoj masi najmanje jedne vrste čestica aktivnog sredstva odabran od iznad 1 i sve do 1.5, sve do 5, sve do 10, sve do 15, sve do 17, sve do 20, sve do 30, sve do 40, sve do 50, sve do 60, sve do 75, sve do 100, sve do 150, te sve do 200.12. Pharmaceutical preparation according to patent claim 1, characterized in that the ratio of the total mass of at least one type of suspended particles to the total mass of at least one type of active agent particles is selected from above 1 and up to 1.5, up to 5, up to 10, up to 15 , up to 17, up to 20, up to 30, up to 40, up to 50, up to 60, up to 75, up to 100, up to 150, and up to 200. 13. Farmaceutski pripravak prema patentnom zahtjevu 12, naznačen time što je omjer ukupne mase najmanje jedne vrste suspendiranih čestica prema ukupnoj masi najmanje jedne vrste čestica aktivnog sredstva odabran od između 3:1 i 15:1 i između 2:1 i 8:1.13. Pharmaceutical preparation according to patent claim 12, characterized in that the ratio of the total mass of at least one type of suspended particles to the total mass of at least one type of active agent particles is selected from between 3:1 and 15:1 and between 2:1 and 8:1. 14. Farmaceutski pripravak prema patentnom zahtjevu 1, naznačen time što sadrži: medij za suspenziju koji sadrži farmaceutski prihvatljiv HFA propelant; prvu vrstu čestica aktivnog sredstva koje sadrže glikopirolat, uključujući sve njegove farmaceutski prihvatljive soli, estere ili solvate, suspendirane u suspenzijskom mediju u koncentraciji dovoljnoj da se osigura isporučena doza glikopirolata od sve do 15 µg to 80 µg po aktiviranju inhalatora s odmjerenom dozom; drugu vrstu čestica aktivnog sredstva koje sadrže formoterol, uključujući sve njegove farmaceutski prihvatljive soli, estere ili solvate suspendirane u suspenzijskom mediju u koncentraciji dovoljnoj da se osigura isporučena doza formoterola od između 2 µg i 10 µg po aktiviranju inhalatora s odmjerenom dozom; i mnoštvo suspendiranih čestica koje se mogu udahnuti koje sadrže perforirane fosfolipidne mikrostrukture koje imaju srednji volumenski optički promjer od između oko 1.5 µm i oko 10 µm, pri čemu se prva i druga vrsta čestica aktivnog sredstva povezuju s mnoštvom suspendiranih čestica tako da nastane ko-suspenzija.14. Pharmaceutical preparation according to claim 1, characterized in that it contains: a suspension medium containing a pharmaceutically acceptable HFA propellant; the first type of active agent particles containing glycopyrrolate, including all its pharmaceutically acceptable salts, esters or solvates, suspended in a suspension medium in a concentration sufficient to ensure a delivered dose of glycopyrrolate of up to 15 µg to 80 µg per actuation of the metered dose inhaler; another type of active agent particles containing formoterol, including any pharmaceutically acceptable salts, esters or solvates thereof suspended in a suspension medium in a concentration sufficient to ensure a delivered dose of formoterol of between 2 µg and 10 µg per actuation of the metered dose inhaler; and a plurality of respirable suspended particles comprising perforated phospholipid microstructures having a volume mean optical diameter of between about 1.5 µm and about 10 µm, wherein the first and second types of active agent particles are associated with the plurality of suspended particles to form a co-suspension. 15. Farmaceutski pripravak prema patentnom zahtjevu 14, naznačen time što je omjer ukupne mase suspendiranih čestica prema ukupnoj masi prve i druge vrste čestica aktivnog sredstva odabran od između 3:1 i 15:1 i između 2:1 i 8:1.15. Pharmaceutical preparation according to claim 14, characterized in that the ratio of the total mass of suspended particles to the total mass of the first and second type of particles of the active agent is selected from between 3:1 and 15:1 and between 2:1 and 8:1. 16. Farmaceutski pripravak prema patentnom zahtjevu 1, naznačen time što je prva vrsta čestica aktivnog sredstva suspendirana u mediju za suspenziju u koncentraciji dovoljnoj da se osigura isporučena doza glikopirolata od do 10 µg po aktiviranju inhalatora s odmjerenom dozom.16. Pharmaceutical preparation according to claim 1, characterized in that the first type of particles of the active agent is suspended in the suspension medium in a concentration sufficient to ensure a delivered dose of glycopyrrolate of up to 10 µg upon activation of the metered dose inhaler. 17. Farmaceutski pripravak prema patentnom zahtjevu 1, naznačen time što je druga vrsta čestica aktivnog sredstva suspendirana u mediju za suspenziju u koncentraciji dovoljnoj da se osigura isporučena doza formoterola od sve do 5 µg po aktiviranju inhalatora s odmjerenom dozom.17. Pharmaceutical preparation according to patent claim 1, characterized in that the second type of particles of the active agent is suspended in the medium for suspension in a concentration sufficient to ensure a delivered dose of formoterol of up to 5 µg upon activation of the metered dose inhaler. 18. Farmaceutski pripravak prema patentnom zahtjevu 1, naznačen time što treća vrsta čestica aktivnog sredstva sadrži budezonid, te se suspendira se u mediju za suspenziju u koncentraciji dovoljnoj da se osigura isporučena doza budezonida od 30 do 240 µg po aktiviranju inhalatora s odmjerenom dozom.18. Pharmaceutical preparation according to patent claim 1, characterized in that the third type of particles of the active agent contains budesonide, and is suspended in a suspension medium in a concentration sufficient to ensure a delivered dose of budesonide of 30 to 240 µg upon activation of the metered-dose inhaler. 19. Farmaceutski pripravak prema bilo kojem prethodnom patentnom zahtjevu naznačen time što je najmanje jedno aktivno sredstvo prisutno u kristalnom ili uglavnom kristalnom obliku.19. Pharmaceutical preparation according to any preceding patent claim, characterized in that at least one active agent is present in crystalline or mainly crystalline form. 20. Farmaceutski pripravak prema bilo kojem prethodnom patentnom zahtjevu naznačen time što su sva aktivna sredstva prisutna u kristalnom ili uglavnom kristalnom obliku.20. Pharmaceutical preparation according to any preceding patent claim characterized in that all active agents are present in crystalline or mainly crystalline form. 21. Inhalator s odmjerenom dozom naznačen time što sadrži pripravak kako je definirano u bilo kojem od zahtjeva 1 do 20.21. A metered dose inhaler comprising a composition as defined in any one of claims 1 to 20. 22. Farmaceutski pripravak kako je definiran u bilo kojem od zahtjeva 1 do 20 naznačen time što je za uporabu u medicini.22. A pharmaceutical composition as defined in any one of claims 1 to 20, characterized in that it is for use in medicine. 23. Farmaceutski pripravak kako je definirano u bilo kojem od zahtjeva 1 do 20 naznačen time što se koristi u postupku liječenja plućne bolesti ili poremećaja kod pacijenta.23. A pharmaceutical composition as defined in any one of claims 1 to 20 for use in the treatment of a pulmonary disease or disorder in a patient. 24. Farmaceutski pripravak za uporabu prema patentnom zahtjevu 23, naznačen time što se plućna bolest ili poremećaj bira od najmanje jednog od astme, KOPB, kroničnog bronhitisa, emfizema, bronhiektazije, alergijskog rinitisa, sinusitisa, plućne vazokonstrikcije, upale, alergija, otežanog disanja, sindroma respiratornog distresa, plućne hipertenzije, upale pluća povezane s cističnom fibrozom, i opstrukcije pluća povezane s cističnom fibrozom.24. Pharmaceutical preparation for use according to claim 23, characterized in that the lung disease or disorder is selected from at least one of asthma, COPD, chronic bronchitis, emphysema, bronchiectasis, allergic rhinitis, sinusitis, pulmonary vasoconstriction, inflammation, allergies, difficulty breathing, respiratory distress syndrome, pulmonary hypertension, cystic fibrosis-related pneumonia, and cystic fibrosis-related pulmonary obstruction. 25. Farmaceutski pripravak za uporabu prema patentnom zahtjevu 24 naznačen time što je bolest ili poremećaj KOPB.25. Pharmaceutical preparation for use according to claim 24 characterized in that the disease or disorder is COPD.
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